Misuse of Drugs Regulations 2017.

• Jurisdiction: Ireland
• Citation: IR SI 173/2017
• Year: 2017

ARRANGEMENT OF REGULATIONS

PART 1

Preliminary and General

1. Citation and commencement.

2. Interpretation.

PART 2

Issuing of Prescriptions by Registered Nurses and Registered Midwives

3. Provisions applicable to practitioners who are registered nurses or registered midwives.

4. Person may refuse to supply drug if reasonable cause to believe conditions referred to in regulation 3 have not been satisfied.

PART 3

Production, Supply, Importation and Exportation of Controlled Drugs

5. General prohibition.

6. Licences.

7. Administration.

8. Exemption for practitioners, pharmacists, etc.

9. Supply.

PART 4

Possession of Controlled Drugs

10. General exemptions.

11. Exemption to possess butan-1,4-diol or dihydrofuran-2(3H)-one.

12. Exemption for midwives in respect of pentazocine and pethidine.

13. General authorities.

PART 5

Documentation and Record-Keeping

14. Documents to be obtained by a supplier.

15. Form of prescriptions.

16. Supply on prescription.

17. Marking of containers.

18. Documents required for export of controlled drugs.

19. Keeping of registers for drugs in Schedules 1 and 2.

20. Record-keeping in particular cases for drugs in Schedule 2.

21. Keeping of records for drugs in Schedules 3 and 4.

22. Preservation of registers, etc.

23. Preservation of records for drugs in Schedules 3, Part 1 of Schedule 4, and Schedule 5.

24. Furnishing of information with respect to controlled drugs.

PART 6

Miscellaneous

25. Destruction of certain drugs.

26. Disposal of certain drugs on cessation of business.

27. Forged, etc. prescriptions.

28. Publication, sale etc. of certain books, periodicals and other publications.

29. References to the revoked Regulations of 1988 in other enactments.

30. Transitional provisions.

SCHEDULES

Schedule 1

Controlled Drugs Subject to the Requirements of Regulations 14, 15, 16, 17, 18, 19, 22, 24, 25, 26 and 28.

Schedule 2

Controlled Drugs Subject to the Requirements of Regulations 14, 15, 16, 17, 18, 19, 20, 22, 24, 25 and 26.

Schedule 3

Controlled Drugs Subject to the Requirements of Regulations 14, 15, 16, 17, 18, 21, 22, 23, 24, 25 and 26.

Schedule 4 Part 1

Controlled Drugs Subject to the Requirements of Regulations 14, 15, 16, 17, 18, 21, 22, 23, 24, 25 and 26.

Schedule 4 Part 2

Controlled Drugs Subject to the Requirements of Regulations 18, 21, 22, 24, 25 and 26.

Schedule 5

Controlled Drugs Exempted from the Prohibition on Importation and Exportation and Subject to the Requirements of Regulation 23.

Schedules 6 and 7

Forms of Register.

Schedule 8

Drugs which Practitioners who are Registered Nurses or Registered Midwives may prescribe within Schedules 2 and 3.

Schedule 9

Provisions of revoked Regulations of 1988 and corresponding provisions in these Regulations.

S.I. No. 173 of 2017

MISUSE OF DRUGS REGULATIONS 2017

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 5th May, 2017.

I, CATHERINE BYRNE, Minister of State at the Department of Health, in exercise of the powers conferred on me by sections 4, 5 (as amended by section 15 of the Misuse of Drugs Act 1984 (No. 18 of 1984), section 4 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006) and section 3 of the Misuse of Drugs (Amendment) Act 2016 (No. 9 of 2016)), 18 and 38 of the Misuse of Drugs Act 1977 (No. 12 of 1977), section 5 of the Misuse of Drugs Act 1984 and the Health (Delegation of Ministerial Functions) (No. 3) Order 2016 ( S.I. No. 511 of 2016 ), hereby make the following regulations:

PART 1

Preliminary and General

Citation and commencement

1. (1) These Regulations may be cited as the Misuse of Drugs Regulations 2017.

(2) These Regulations come into operation on 4 May 2017.

Interpretation

2. (1) In these Regulations—

“Act of 2006” means the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006);

“Acts relating to merchant shipping” means the Merchant Shipping Acts 1894 to 2014;

“authorised as a member of a group” means authorised by virtue of being a member of a class in respect of which the Minister, under section 4 of the Principal Act, has granted an authority which is in force under and for the purposes of Regulation 9(2) and “his or her group authority” in relation to a person who is a member of such a class means the authority so granted to that class;

“Director of Nursing or Director of Midwifery or Matron” includes a person acting in that capacity;

“Clinical Nurse Manager or Clinical Midwife Manager or Sister” includes a person acting in that capacity;

“Directive 2001/83/EC” means Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20011 ;

“Executive” means the Health Service Executive;

“health prescription” and “health service requisition” mean, respectively, a prescription or a requisition issued in connection with arrangements made under section 59 of the Health Act 1970 (No. 1 of 1970) upon a form supplied by or on behalf of the Executive;

“installation manager”, “offshore installation” and “Industrial Medical Adviser (Offshore Installations)” have the meanings assigned to them by the Safety, Health and Welfare (Offshore Installations) Act 1987 (No. 18 of 1987);

“marketing authorisation” means an authorisation or licence which is for the time being in force and which has been granted by—

(a) the Health Products Regulatory Authority in accordance with—

(i) the Medicinal Products (Control of Placing on the Market) Regulations 2007 ( S.I. No. 540 of 2007 ), including a product authorisation or a parallel import licence, or

(ii) Article 126a of Directive 2001/83/EC,

(b) the European Commission under Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 20042 ,

(c) the competent authority of a state which is a contracting party to the Agreement on the European Economic Area signed in Oporto on 2 May 1992, as adjusted by the Protocol to that Agreement done at Brussels on 17 March 19933 , in accordance with Article 6 of Directive 2001/83/EC, or

(d) the competent authority in the Swiss Confederation for the granting of authorisations or licences for the marketing of medicinal products;

“master” has the meaning assigned to it in the Acts relating to merchant shipping;

“medicinal product” has the meaning assigned to it by Directive 2001/83/EC, as amended from time to time;

“the Minister” means the Minister for Health;

“officer of customs” has the meaning assigned to it by the Customs Act 2015 (No. 18 of 2015);

“An Post” means the company referred to in section 10 (1)(a) of the Postal and Telecommunications Services Act 1983 (No. 24 of 1983);

“person carrying on a retail pharmacy business” means a person carrying on a retail pharmacy business in accordance with regulation 26(1) of the Pharmacy Act 2007 (No. 20 of 2007);

“practitioner” means a registered medical practitioner, a registered dentist, a registered veterinary practitioner or, subject to regulation 3, a registered nurse or registered midwife;

“prescription” means a prescription issued by—

(a) a registered medical practitioner for the medical treatment of an individual,

(b) a registered dentist for the dental treatment of an individual,

(c) a registered veterinary practitioner for the purposes of animal treatment, or

(d) subject to Regulation 3, a registered nurse or registered midwife for the medical treatment of an individual;

“Principal Act” means the Misuse of Drugs Act 1977 (No. 12 of 1977);

“prison” has the meaning assigned to it by the Prisons Act 2007 (No. 10 of 2007), as amended by the Prisons Act 2015 (No. 57 of 2015);

“prison officer” means an officer of the Minister for Justice and Equality assigned to perform the duties of a prison officer;

“produce”, where the reference is to producing a controlled drug, means produce by cultivation, manufacture, synthesis or any other method;

“registered veterinary practitioner” means a person registered under Part 4 of the Veterinary Practice Act 2005 (No. 22 of 2005);

“registration number” means—

(a) in the case of a registered medical practitioner, the number attached to the medical practitioner’s registration in accordance with section 43(5) of the Medical Practitioners Act 2007 (No. 25 of 2007),

(b) in the case of a registered veterinary practitioner, the identification number issued to the veterinary practitioner for the purposes of registration under section 37 of the Veterinary Practice Act 2005 ,

(c) in the case of a registered nurse or registered midwife, the number attached to the nurse’s or midwife’s registration in accordance with section 46(7) of the Nurses and Midwives Act 2011 (No. 41 of 2011), or

(d) in the case of a registered dentist, the number assigned by the Dental Council to the registration in the Register of Dentists in accordance with section 26 of the Dentists Act 1985 (No. 9 of 1985);

“Regulations of 1988” means the Misuse of Drugs Regulations 1988 ( S.I. No. 328 of 1988 ) (revoked by section 7 of the Misuse of Drugs (Amendment) Act 2016 (No. 9 of 2016));

“retail pharmacy business” has the meaning assigned to it by the Pharmacy Act 2007 ;

“the State Chemist” means the head of the State Laboratory;

“wholesaler” means a person who carries on the business of selling controlled drugs to persons for the purpose of resale.

(2)(a) Subject to subparagraph (b), in these Regulations, other than in the case of a register referred to in Regulation 9 or 10, “register” means a bound book and does not include any form of loose leaf register or card index.

(b) In the case of—

(i) the holder of a manufacturer’s authorisation, as defined in Regulation 3 of the Medicinal Products (Control of Manufacture) Regulations 2007 ( S.I. No. 539 of 2007 ), where the activities to be recorded in the register are related to those subject...